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NEW YORK, March 09, 2026 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the publication of data from a post hoc pooled analysis of the Phase 3 ULTIMATE I and II studies evaluating BRIUMVI® (ublituximab-xiiy) in people with highly active relapsing forms of multiple sclerosis (RMS). The article, authored by Hans-Peter Hartung, MD, of Heinrich Heine University Düsseldorf and colleagues, was published in Neurology and Therapy. The analysis evaluated efficacy outcomes in participants with highly active disease at baseline, defined as ≥2 relapses in the year prior and ≥1 gadolinium-enhancing (Gd+) T1 lesion at baseline. Results demonstrated statistically significant reductions in relapse rates and MRI activity, as well as significantly higher rates of no evidence of disease activity (NEDA-3), with BRIUMVI compared to teriflunomide. Additional details from the publication are included below.
Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer stated, “The publication of these data from a post hoc pooled analysis in Neurology and Therapy further reinforces the efficacy of BRIUMVI to treat people with highly active relapsing MS — a population at risk for rapid disease progression and disability accumulation. These results demonstrate robust and rapid reductions in both clinical and radiologic disease activity and support the use of a high-efficacy therapy such as BRIUMVI early in the disease course.”
Hans-Peter Hartung, MD, Professor of Neurology at Heinrich Heine University Düsseldorf and lead author of the publication noted, “In this subgroup of patients with highly active disease at baseline, ublituximab was associated with significant improvements across multiple measures, including relapse rate, MRI lesion burden, and NEDA-3 outcomes. Benefits were observed as early as Week 12 and sustained through 96 weeks. These findings highlight the importance of early, high-efficacy treatment in individuals with more aggressive disease.”
The article can be accessed at the Neurology and Therapy website or at our TG Therapeutics publication page.
Title: Efficacy of Ublituximab in People with Highly Active Relapsing Multiple Sclerosis
The post hoc pooled analysis included 168 participants with highly active disease at baseline (ublituximab, n=88; teriflunomide, n=80) from the ULTIMATE I and II trials. Participants were followed for 96 weeks. Highly active disease was defined as ≥2 relapses in the year prior to screening and ≥1 Gd+ T1 lesion at baseline.
Key Efficacy Results
